Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate the safety and immunogenicity of rvsv∆g-lasv-gpc vaccine in adults in good general heath

Conditions: Lassa Fever; Lassa Virus Infection

Summary: a phase 1 randomized, double-blinded, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of rvsv∆g-lasv-gpc vaccine in adults in good general health

this is a phase 1 randomized, double-blinded, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of rvsv∆g-lasv-gpc vaccine in adults in good general health. approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study participants will be screened up to 42 days before ip administration and will be followed for 12 months after ip administration.

Eligibility criteria:
inclusion criteria 1. adults in good general health as assessed by medical history, physical examination, and laboratory tests 2. at least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination 3. willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study 4. willing to undergo hiv testing, risk reduction counselling, and receive hiv test results 5. use effective method of contraception 6. understand the study and provide written informed consent exclusion criteria 1. confirmed hiv-1 or hiv-2 infection 2. any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease 3. any clinically significant chronic medical condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study 4. pregnant or lactating 5. bleeding disorder that was diagnosed by a physician 6. prior receipt of another investigational lassa vaccine candidate 7. receipt of blood transfusion or blood-derived products within the previous 3 months 8. prior exposure to lasv as documented by history 9. history of severe local or systemic reactogenicity to any vaccine 10. body mass index (bmi) ≥35 11. mild or greater hearing impairment defined as ≥26db loss in either ear
does ultrasound guidance improve time to perform a spinal or number of attempts in obese patients?

Conditions: Spinal Anesthesia Administration

Summary: spinal anesthesia depends on being able to locate physical landmarks on a patient's body. in obese patients, the commonly used landmarks may be difficult or even impossible to feel. in addition, the spine can be hidden beneath a layer of fatty tissue. ultrasound is useful for finding the correct injection site in pregnant patients, but the usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. the potential benefits for obese patients from the use of ultrasound include shortening the duration of the procedure, increasing patient comfort, decreasing the total number of attempts, and aiding in the choice of appropriate needle length for the patient. the investigators hypothesize that there is no difference in time to perform a spinal anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients with bmi \> 35.


Eligibility criteria:
inclusion criteria: * patients undergoing surgeries amenable to spinal anesthetic * bmi \>35 * between the ages of 18-85 exclusion criteria: * patients with known spinal disease or previous spinal surgery * pregnant patients * patients requiring emergent surgeries * patients in positions other than sitting during neuroaxial anesthesia * patients with contraindications to neuroaxial anesthesia
effectiveness and safety of iv zemplar in patients on hemodialysis and with secondary hyperparathyroidism using ipth/100 as initial dose

Conditions: Secondary Hyperparathyroidism; Renal Insufficiency, Chronic; Parathyroid Hormone; Hemodialysis; Hypercalcemia

Summary: the purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (ipth/100) in chronic kidney disease patients with secondary hyperparathyroidism (pth\>300pg/ml) and that require dialysis at least 3 times per week.

the study will be carried out in three dialysis centers in peru. each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. study visits will occur at baseline and at weeks 4, 8, 12 and 24 during the study.

Eligibility criteria:
inclusion criteria: * patients \>=18 years old with secondary hyperparathyroidism (pth\>300pg/ml, measured in the last 2 weeks). * patients on hemodialysis who require starting therapy with iv paricalcitol (de novo). * patients attending 3 hemodialysis sessions per week. * patients signing the informed consent approved by the ethics committee. if any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations. * the decision to initiate treatment is upon the investigator and the decision to treat patients with iv paricalcitol must not be based on the inclusion of the patient in the study or any other way. the decision to treat a patient with iv paricalcitol will be taken prior to asking the patient to participate in the study. exclusion criteria: * patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response. * patients with severe hyperparathyroidism (pth\>3000pg/ml). * patients with a serum calcium level greater or equal to 10.5mg/dl, phosphorus greater or equal to 6.5mg/dl, or those with calcium x phosphorus product 65 (measured at least 2 weeks before the study). * patients with neoplastic disease. * pregnant or lactating women. * known hypersensitivity and/or toxicity to vitamin d metabolites and/or to other ingredients of the product. * having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study. * use of vitamin d analogue during the last 3 months prior to the inclusion to this study.
a pilot study of fluconazole plus flucytosine for the treatment of aids patients with acute cryptococcal meningitis.

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with aids. fluconazole and flucytosine have different mechanisms of action. since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin b plus flucytosine.

fluconazole and flucytosine have different mechanisms of action. since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin b plus flucytosine. patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. therapy continues until 8 weeks after the csf becomes culture negative, up to a maximum of 26 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiviral therapy (azt, dhpg). * prophylaxis for pneumocystis carinii pneumonia. * treatment for intercurrent opportunistic infection. concurrent treatment: allowed: * radiation therapy for mucocutaneous kaposi's sarcoma. patients must have: * aids. * evidence of cryptococcal neoformans in culture or lumbar csf or clinical and csf findings compatible with cryptococcal meningitis. * no evidence of acute or chronic meningitis of any etiology other than cryptococcosis. * life expectancy of at least 2 weeks. prior medication: allowed: * prior antiviral therapy (azt, dhpg). * prophylaxis for pneumocystis carinii pneumonia. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * relapsing on maintenance triazole therapy for cryptococcal meningitis. * unable to take oral medication. concurrent medication: excluded: * concomitant use of any antifungal agent other than study drug. patients with the following prior conditions are excluded: history of allergy to or intolerance of imidazoles, azoles, or flucytosine. prior medication: excluded: * more than 1 mg/kg amphotericin b. * systemic antifungal agents within 7 days prior to study entry.

Keywords: meningitis cryptococcosis drug therapy, combination fluconazole flucytosine acquired immunodeficiency syndrome
powerspiral enteroscopy performance and safety

Conditions: Small Bowel Disease

Summary: multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.

background and aims: motorized spiral enteroscopy is a recent advancement in enteroscopy. data are scarce on the utility and safety of the motorized spiral enteroscopy. no data is available on the utility of this technique in patients with altered gastrointestinal (gi) anatomy. this study aimed to evaluate the efficacy of motorized spiral enteroscopy including rate of total enteroscopy (ter) in patients undergoing enteroscopy for suspected small bowel disease including those with altered gi anatomy. methods: a multicenter prospective study evaluated consecutive patients with symptomatic small bowel disease who underwent enteroscopy over a 12-month period.

Eligibility criteria:
inclusion criteria: 1. age 18 years and older 2. patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy 3. written informed consent exclusion criteria: 1. contraindications for endoscopy because of comorbidities 2. unable to provide written informed consent 3. patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure 4. coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion 5. pregnant patients 6. health status: american society of anesthesiologists (asa) class \>3 7. inability to tolerate propofol sedation or general anesthesia for any reason

Keywords: motorized spiral enteroscopy device-assisted enteroscopy
light therapy for moderate traumatic brain injury

Conditions: Moderate Traumatic Brain Injury (TBI)

Summary: the purpose of this research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (lllt) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (tbi).

the specific aim of this pilot study is to determine the feasibility of using the lllt helmet in patients with moderate tbi and to quantify the response to lllt using magnetic resonance (mr) and clinical outcome measures. we hypothesize that we will be able to quantify the response to lllt through mr imaging and clinical outcome measures.

Eligibility criteria:
inclusion criteria: * at least 18 years old; * injury within 72 hours at the time of consent; * head injury requiring hospital admission; * a glasgow coma scale (gcs) score of 9-12 or 13-15 with abnormal imaging. exclusion criteria: * need for emergency neurosurgical intervention (including placement of intracranial pressure monitoring devices or drainage catheters); * hemodynamic instability as determined by the clinician; * history of any of the following: (i) brain tumor; (ii) prior tbi occurring within the past year and requiring hospital admission; (iii) a new diagnosis within the past year of either stroke or epilepsy; (iv) an established diagnosis of any of the following neurodegenerative diseases: alzheimer's, picks, parkinson's, lewy body dementia, huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia, hiz-associated dementia, dementia due to metabolic causes (addison, cushing, hypothyroidism, renal failure, prophyrias, wilson, mitochondrial diseases, wernicke-korsakoff syndrome, and dementia of unknown etiology. * pregnancy (all women of child-bearing age will need to have a negative pregnancy test prior to the start of the interventional portion of the study); * electrical implants such as cardiac pacemakers or perfusion pumps; * ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, or any other contra-indications to mri. * clinical determination that subject cannot undergo mri * breastfeeding * unstable cervical fractures * scalp lacerations or surgical wounds severe enough to preclude safe application of device * unreliable to follow up

Keywords: traumatic brain injury tbi low-level light therapy lllt lllt helmet
allogeneic tumor cell vaccination in patients with chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: donors with cm will be solicited from a waiting list of patients awaiting bmt from the waiting list of mud searches. maximally matched donor will be searched for each eligible cml patient with a goal in mind to find other patients with cml that share both class i and class ii determinants. sharing of one class i ii will be considered eligible for participation in the study. peripheral blood and pbmc from the donors will be isolated, washed and irradiated. the cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.


Eligibility criteria:
inclusion criteria: * patients above the age of 55 consenting to participate in the study. * patients with documented cml with philadelphia chromosome t (9:21) * patients with no hla matched sibling. * patients eligible for bmt for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed bmt. * patients with contra-indication to bmt. * patients refusing bmt. * patients who failed interferon alpha, arac and/or glivec. exclusion criteria: * patients requiring immunosuppressive therapy or corticosteroids.
a study of ibi362 in participants with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this trial is conducted in china. the aim of the trial is to evaluate efficacy and safety of ibi362 versus dulaglutide as add-on to metformin and/or sglt2 inhibitor or tzd in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. t2d was diagnosed according to who standards in 1999 for 2. age ≥ 18 when signing the informed consent form 3. after used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with sglt2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤hba1c≤11.0%. 4. bmi≥23 kg/m2 at screening. 5. subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol exclusion criteria: 1. subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. weight change\>5% within 12 weeks before screening (chief complaint) 3. oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening. 4. previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes 5. there are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) 6. mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study 7. pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period 8. the investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
do low high density lipoprotein (hdl) levels predict treatment outcome in patients with chronic hepatitis c viral infection?

Conditions: Chronic Hepatitis C Viral Infection

Summary: the working hypothesis is that the low hdl serum level predict favorable response to anti viral treatment in chronic hcv (genotype 1) viral infection. this might be used to improve the rate of sustained virologic response.

lipoproteins are closely connected to the process of hepatitis c virus (hcv) infection. metabolic syndrome predicts negative treatment outcome in hcv infection. aim: to assess the association between lipids components of the metabolic syndrome and sustained viral response (svr).

Eligibility criteria:
inclusion criteria: * chronic hcv genotype 1 naive patients exclusion criteria: * co infection with hbv, hiv, hdv * decompensated liver disease

Keywords: svr cholesterol level fibrosis score hdl
quality of life while receiving faslodex

Conditions: Breast Cancer

Summary: to study qol related response, symptom spectrum and severity in disseminated breast cancer patients receiving faslodex hormonal therapy.


Eligibility criteria:
inclusion criteria: * histologic and/or cytological proven breast cancer. * patients with metastases of breast cancer ± postmenopausal primary tumor ≥12 months. * positive oestrogen receptors (er+), positive progesterone receptors (pgr+) or unknown hormonal receptors (if duration between surgery and metastasis occurring is not less 2 years) which are indirect confirmation of hormone sensitive tumor. * ecog performance status of ≤ 2 * patient willingness to take part in the programm * life expectancy of more than 6 months. * patient ability to complete a questionnaire. exclusion criteria: * contraindications for faslodex therapy * other anticancer therapy (chemotherapy, hormonal therapy with other drugs, radiotherapy), except for radiotherapy of sites which are not only measurable or evaluable manifestation of disease.

Keywords: quality of life postmenopausal women hormone receptor positive disseminated breast cancer faslodex
impact of humor prescription on the emotional well-being of patients with medically unexplained symptoms: a quasi-experimental study

Conditions: Medically Unexplained Symptoms

Summary: this study aims to study the effectiveness of the intervention for medically unexplained symptoms(mus) in terms of changes in emotional well-being before and after the intervention (humor therapy)


Eligibility criteria:
inclusion criteria: participants may be included in the trial if they meet all of the following inclusion criteria: men and women over 18 years of age. diagnosed with the condition under study (see section 2: definitions). expected to undergo follow-up for their condition at the study center. ability to participate in the required assessments. legal capacity to provide informed consent. signed informed consent for inclusion in the study, either by the participant or their legal representative. exclusion criteria: participants will be excluded if they meet any of the following exclusion criteria: participants diagnosed with any of the following conditions: severe mental health disorder, as determined by the investigator cognitive impairment of any etiology, as recorded in the medical history treatment for the condition under study using community-based resources prescribed in primary care within the past 6 months. cognitive or affective disorders that limit the ability to comply with study procedures. participation in another study involving an experimental intervention during the period of the present trial and/or requiring visit schedules that are incompatible with this trial.

Keywords: medically unexplained symptoms
bone flap osteomyelitis following craniectomy : retrospective evaluation of clinical presentation, microbiological diagnosis and management

Conditions: Osteitis; Cranial Flap

Summary: osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.


Eligibility criteria:
inclusion criteria: * patients with cranial flap osteitis after craniectomy * patients who did not object to participating in the study * adult patients exclusion criteria: * na

Keywords: osteitis cranial flap
safety, tolerability and immunogenicity of three doses of novartis meningococcal b vaccine when administered to healthy at-risk adults

Conditions: Meningococcal Disease

Summary: this study is aimed to evaluate safety, tolerability and immunogenicity of three doses of novartis 4cmenb and of one dose of novartis meningococcal acwy vaccine when administered to healthy at-risk adults.


Eligibility criteria:
inclusion criteria: * healthy adults,18 through 50 years of age, who were or might be routinely exposed to n. meningitidis cultures exclusion criteria: * previous ascertained or suspected disease caused by n. meningitidis; * pregnancy or breastfeeding; * history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; * any present or suspected serious acute or chronic disease * known or suspected autoimmune disease or impairment /alteration of immune function

Keywords: meningococcal disease prevention vaccination